MAUDE Adverse Event Report: DEPUY SYNTHES SPINE HIGH VISC SPINAL CEMENT, 11CC; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 183901000

Device Problems Filling Problem (1233); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2014

Event Type  malfunction  

Event Description

Per international affiliate, the physician reported that product has frozen one minute after mixing cement with solvent (had been mixed about 1 minute).The cement is reported to have set up too quickly.Another kit was available for use.The resulting delay was reported to be not more than twenty minutes with no adverse consequences to the patient.

Manufacturer Narrative

A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not returned.

Manufacturer Narrative

The high visc spinal cement, 11cc was not returned for evaluation.A review of the device history record (dhr) identified no issues during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A review of the complaint trend analysis found no related complaints.No issues were identified in the manufacturing and release of these products that could have contributed to the problem reported by the customer and no systemic trend observed in this complaint file.As such, this complaint file will be closed with no further actions required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The complaint product is available for the investigation.A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The product samples returned to the complaints handling unit (chu) for evaluation.Visual examination of the returned confidence mixer handle found light hardened cement residue on the handle body.Additionally, it was noted that there was leftover hardened cement inside the mixing well.Observations also confirm that the cement was homogenous.A confidence pump along with the cement reservoir was also returned.Visually, nothing could be found wrong with device.It should also be noted that the confidence pump is a concomitant device which did not contribute to the failure indicated by the customer.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.The root cause of the cement becoming solid after connecting cement with solvent cannot be positively determined.A potential root cause may be due to the environment of the storage location or use of the cement.Per the instructions for use (ifu-0902-90-055 revision e), it is noted that with the operating room and material temperature of 20 degrees celsius, the different phases are as follows: mixing: 40-60 seconds, filling the delivery system: 1-2 minutes, application phase: 9 minutes, and hardening (setting): 4 minutes.Also, acrylic cements are heat sensitive.Any increase or decrease in temperature (either ambient, and/or of the cement components), from the recommended temperature of 68 degrees fahrenheit (20 degrees celsius) will affect the handling characteristics and setting time of the cement.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HIGH VISC SPINAL CEMENT, 11CC
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): TEKNIMED SAS; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 4228082
• MDR Text Key: 4969542
• Report Number: 1526439-2014-12061
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 183901000
• Device Lot Number: 043D13411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONFIDENCE KIT, 283913000